Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies (PRESeNT)

July 10, 2023 updated by: Annamaria Cattaneo, IRCCS Centro San Giovanni di Dio Fatebenefratelli

Exposures to PRenatal and Postnatal Adverse Stressful Experiences: Multimodal Omics Signatures Underlying Stress Vulnerability and Resilience and as Novel Targets for Preventive Strategies.

The study aims at identifying:

  1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
  2. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk;
  3. whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women;

In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum.

Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health.

Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses.

Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses.

Clinical and psychological data will be collected from women at all timepoints.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Brescia, Italy, 25125
        • Active, not recruiting
        • IRCCS Centro San Giovanni di Dio Fatebenefratelli
      • Milano, Italy
        • Not yet recruiting
        • Ospedale San Raffaele
        • Contact:
          • Francesco Benedetti
      • Milano, Italy
        • Not yet recruiting
        • Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco
        • Contact:
          • Roberta Anniverno
      • Treviglio, Italy
        • Recruiting
        • ASST Bergamo Ovest
        • Contact:
          • Marina Cattaneo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women of a singleton pregnancy
  • Age ≥ 18 years

Exclusion Criteria:

  • Uterine anomalies and obstetric complications
  • Comorbidity with severe or chronic diseases
  • Substance abuse
  • Language barrier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Procedure: Blood and saliva collection
Blood and saliva samples from pregnant women; saliva samples from babies.
Behavioral: Psychometric scales
A battery of psychometric scales and questionnaires.
Other: Smartphone app
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
Other: Depressed
Procedure: Blood and saliva collection
Blood and saliva samples from pregnant women; saliva samples from babies.
Behavioral: Psychometric scales
A battery of psychometric scales and questionnaires.
Other: Smartphone app
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
Other: At high risk
Procedure: Blood and saliva collection
Blood and saliva samples from pregnant women; saliva samples from babies.
Behavioral: Psychometric scales
A battery of psychometric scales and questionnaires.
Other: Smartphone app
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differentially expressed genes and biological pathways modulation
Time Frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate and profile of DNA methylation
Time Frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Cortisol levels
Time Frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Immune-related factors levels
Time Frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Smartphone app utility
Time Frame: From 25th of gestation to 12 months postpartum
From 25th of gestation to 12 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 10, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRESeNT
  • 1749118 (Other Grant/Funding Number: FRRB - Fondazione Regionale per la Ricerca Biomedica)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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